Why it was recalled
Lack of Assurance of Sterility
Product description
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Lot numbers, UPCs & expiration codes
Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1545-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 641,160 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-1545-2022, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90864
- Address
- 10 Independence Blvd
- Code information
- Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
- Postal code
- 07059-2730
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-1545-2022
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 641,160 ampules
- Termination date
- Jan 10, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Sep 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2022